Retinopathy of Prematurity Clinical Trial
Official title:
Special Drug Use Investigation for Eylea for Retinopathy of Prematurity (ROP)
This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without specified advice or interventions. ROP is a condition that affects the eye and occurs only in babies who are born too early. Most cases of ROP are mild and get better without treatment, but more serious cases need to be treated in time. ROP happens when the blood vessels in the "retina" grow abnormally. The retina is the layer of tissue at the back of the eye that picks up light and sends messages to the brain. In babies with ROP, these abnormal blood vessels can leak. This causes damage to the retina and can sometimes move it out of place causing medical problems such as blindness. Eylea is received as an injection into the eye. It works by blocking a certain protein (VEGF) that can cause blood vessels in the retina to grow abnormally. Eylea is already available in Japan and is approved for doctors to prescribe to babies with ROP. The participants in this study are Japanese babies with ROP that their doctors decided to treat with Eylea before the start of this study. Babies with ROP that were already prescribed Eylea by their doctors may also be included. The main purpose of this study is to collect more data on how safe the treatment with Eylea is in babies with ROP under a real-world setting. Another purpose of this study is to collect more data on how well Eylea works in these participants. To see how safe Eylea is, the study doctors will collect all medical problems that the participants treated with Eylea have. These medical problems are called adverse events. Doctors keep track of all the adverse events that happen, even if they do not think that they might be related to the treatment. To see how well Eylea works, the study doctors will check the number of participants: - with no active ROP after starting treatment - where ROP came back up to 6 months after start of treatment In this study, the study doctor will: - collect past data of the participants from medical records - interview the participants - collect treatment-related data during routine visits. The study duration is 6 months with 3 planned visits. One visit will be at start of treatment, one at one month and one at 6 months after start of treatment. All data required for this study will be collected during routine visits. Besides this data collection, no further tests or examinations are planned in this study.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043077 -
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
|
Phase 4 | |
Completed |
NCT04838665 -
Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study
|
Phase 4 | |
Completed |
NCT04408807 -
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
|
N/A | |
Recruiting |
NCT03083431 -
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
|
Phase 2 | |
Enrolling by invitation |
NCT04985448 -
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
|
||
Recruiting |
NCT02090322 -
Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1
|
N/A | |
Completed |
NCT00872664 -
Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids
|
N/A | |
Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT06452524 -
Prematurity and Ophthalmological Changes
|
||
Completed |
NCT04101721 -
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
|
Phase 3 | |
Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
Terminated |
NCT01335113 -
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
|
||
Active, not recruiting |
NCT00027222 -
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
|
Phase 2/Phase 3 | |
Recruiting |
NCT06109285 -
Validation of i-ROP DL to Detect More Than Mild ROP
|
N/A | |
Completed |
NCT01861470 -
REDEXAM - Reducing Painful Eye Examinations in Preterm Infants
|
N/A | |
Completed |
NCT02014454 -
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
|
Phase 2 | |
Terminated |
NCT00634972 -
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
|
Phase 4 | |
Completed |
NCT05701124 -
Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity
|
Phase 3 | |
Completed |
NCT04092127 -
Pain of Premature Babies and RetCam (DOLICAM)
|
||
Completed |
NCT04621136 -
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
|
Phase 1/Phase 2 |